Device for treatment of aneurysm

ABSTRACT

In a method, system and device for treating aneurysm a member is placed around the aneurysm, the aneurysm can be treated and monitored. The member can comprise a sensor placed in relation to a wall portion of the aneurysm for generating a signal corresponding to a parameter related to the aneurysm or the treatment of the aneurism. For example the size of the aneurysm such as the diameter of the aneurysm can be monitored. Hereby changes in the aneurism can be detected and information about the changes of the aneurysm can be used when determining how to treat the aneurysm.

TECHNICAL FIELD

The present invention relates to a method and a device for treating avascular aneurysm of a human or mammal patient.

BACKGROUND

An aneurysm (or aneurism) is a localized, blood-filled dilation(balloon-like bulge) of a blood vessel caused by disease or weakening ofthe vessel wall. Aneurysms most commonly occur in arteries at the baseof the brain (the circle of Willis) and in the aorta (the main arterycoming out of the heart), a so-called aortic aneurysm. The bulge in ablood vessel can burst and lead to death at any time. The larger ananeurysm becomes, the more likely it is to burst and since aneurysmsnaturally grow, given enough time they will inevitably reach thebursting point if undetected.

Given the severe consequences of an aneurysm screening is now commonlyperformed in order to early detect the presence of an aneurism. In caseof an aortic aneurism the blood-filled dilation is commonly located inthe abdomen close to the Y-bifurcation extending to the legs. At thislocation the aorta is typically about 2.5 centimeters wide, which can bemeasured for example using ultra-sonic or X-ray based measuring devices.

Existing treatment when detecting an aortic aneurysm includesimplantation of a stent around the vessel using open surgery. Analternative surgical procedure is to implant a tube from the groin anguide the stent via arteria femoralis into position where the blood flowcan by-pass the aortic aneurysm via the tube. The latter treatment hasthe drawback that an embolism easily is formed when introducing alienmaterial into the bloodstream.

Hence, there exists a need for a treatment of aortic aneurysm that ismore robust and which brings about fewer complications.

SUMMARY

It is an object of the present invention to overcome or at least reducesome of the problems associated with treatment and monitoring of ananeurysm.

This object and others are obtained by the method, system and device asset out in the appended claims. Thus, by providing a member around theaneurysm, the aneurysm can be treated and monitored.

In accordance with one embodiment a sensor for monitoring a vascularaneurysm of a human or mammal patient is provided. For example themember can comprise a sensor placed in relation to a wall portion of theaneurysm for generating a signal corresponding to a parameter related tothe aneurysm or the treatment of the aneurism. For example the size ofthe aneurysm such as the diameter of the aneurysm can be monitored.Hereby changes in the aneurism can be detected and information about thechanges of the aneurysm can be used when determining how to treat theaneurysm.

In accordance with one embodiment a sensor is adapted to measure thevolume of a hydraulic implantable member.

In a preferred embodiment, the system comprises at least one switchimplantable in the patient for manually and non-invasively controllingthe device,

In another preferred embodiment, the system comprises a wireless remotecontrol for non-invasively controlling the device.

In a preferred embodiment, the system comprises a hydraulic operationdevice for operating the device.

In one embodiment, the system comprises comprising a motor or a pump foroperating the device.

The invention also extends to methods for implanting the device.

Any feature in any of the four combinations of features in thecombination embodiments described below may be used in any combinationand furthermore in combination with any other feature or embodimentdescribed in any of the other figures or figure text or descriptions inthis application.

First Combination Embodiments Includes Electrical Stimulation Comprising

A medical device including a stimulation device for treating a vascularaneurysm of a human or mammal patient comprising:

-   -   at least one implantable electrode adapted to placed in close        connection to the aneurysm, the at least one electrode being        adapted to provide an electrical stimulation pulse on a wall        portion of the aneurysm.

At least one electrode is adapted to stimulate multiple stimulationpoints. Alternatively at least two electrodes are provided and whereingroups of stimulation points are controllable to be individuallystimulated.

A pulse generator adapted to generate positive and negative electricalstimulation pulses.

Electrical stimulation pulses, which may have a constant current andpreferable the stimulation device deliver the electrical stimulationpulse as pulse train stimulation with breaks to allow the vessel torest.

A stimulation device that deliver the electrical stimulation pulses atdifferent time intervals.

A device preferable delivering the electrical stimulation pulse as apulse width modulated stimulation pulse.

A stimulation device preferable deliver the electrical stimulation pulseduring the systolic phase.

A stimulation device further comprising a monitoring system fordetecting an expansion of the aneurysm. Also to avoid any fast expansionand burst leading to death.

If so said monitoring system may increase intensity and or position ofthe stimulation, when detecting an expansion of the aneurysm.

A method of treating an aneurysm of a mammal patient by providing themedical device according to any feature disclosed herein, comprising thesteps of:

inserting a needle or a tube like instrument into the patient'sabdominal cavity,

using the needle or tube like instrument to fill a part of the patient'sbody with gas and thereby expanding said abdominal cavity,

placing at least two laparoscopic trocars in said cavity,

inserting a camera through one of the laparoscopic trocars into saidcavity,

inserting at least one dissecting tool through one of said at least twolaparoscopic trocars,

dissecting an area of an aneurysm of a blood vessel,

placing said medical device, comprising a stimulation device, onto saidthe aneurysmic blood vessel, and

stimulating said aneurysm to increase the tonus of the aneurysm wall.

An alternative method of treating an aneurysm of a mammal patient byproviding the medical device including any feature disclosed herein,comprising the steps of:

inserting a needle or a tube like instrument into the patient'sthoraxial cavity,

using the needle or tube like instrument to fill a part of the patient'sbody with gas and thereby expanding said thoraxial cavity,

placing at least two laparoscopic trocars in said cavity,

inserting a camera through one of the laparoscopic trocars into saidcavity,

inserting at least one dissecting tool through one of said at least twolaparoscopic trocars,

dissecting an area of an aneurysm of a blood vessel,

placing said medical device, comprising a stimulation device, onto saidthe aneurysmic blood vessel, and

stimulating said aneurysm to increase the tonus of the aneurysm wall.

An alternative method of treating an aneurysm of a mammal patient byproviding the medical device including any feature disclosed herein,said method comprising the steps of:

cutting the skin in the abdominal or thoraxial wall of said mammalpatient,

dissecting an area of the aneurysm,

placing said medical device, comprising a stimulation device, onto saidaneurysm, and

stimulating said aneurysm to increase the tonus of the aneurysm wall.

A method of treating an aneurysm of a mammal patient by providing themedical device including any feature disclosed herein, said methodcomprising the steps of:

cutting the skin of said mammal patient,

dissecting an area of the aneurysm,

placing said medical device, comprising a stimulation device, onto saidaneurysm, and

stimulating said aneurysm to increase the tonus of the aneurysm wall.

Additionally a computer program product comprising computer programsegments that when executed on a computer causes the computer togenerate a pattern of signals for an implantable electrode adapted toplaced in close connection to an aneurysm, the at least one electrodebeing adapted to provide an electrical stimulation pulse on a wallportion of the aneurysm.

A device including a digital storage medium comprising the computerprogram product.

Second Combination Embodiments Includes a Hydraulic System PuttingPressure on the Aneurysm Comprising

A device for treating an aneurysm of a human or mammal patientcomprising:

-   -   An implantable member adapted to hold fluid, wherein said member        is adapted to be placed in connection with a blood vessel having        the aneurysm, the member being adapted to exercise a pressure on        the aneurysm of said blood vessel.

A device preferable adapted to prevent or reduce an expansion of saidaneurysm.

A device adapted to be postoperatively adjusted. The device is normallynon-invasively adjustable.

A device preferable adapted to perform self adjustments of the pressureapplied onto said aneurysm within a predetermined treatment interval.

A device normally comprising a control unit and a sensor, the controlunit being adapted to control pressure adjustments of based on a signalgenerated by the sensor.

The sensor may comprise any type of sensor. Preferable a pressureregulator is adapted to regulate the pressure in the member, wherein thepressure regulator preferable is adapted to even out the difference inpressure in the implantable member during the systolic and diastolicphase for reducing the pressure difference or providing a substantiallyeven outside pressure on the aneurysm. The pressure regulator maycomprise pressure tank.

A implantable member which is alternatively Y-shaped, wherein theimplantable Y-shaped member normally is adapted to be placed at theAorta Bifurcation

A pressure regulator in one embodiment comprises an expandable firstreservoir.

The expandable first reservoir preferable is spring loaded.

A device wherein the pressure regulator in a preferred embodimentcomprises a pump.

A device further comprising a second reservoir and a pump adapted tomove liquid between the first and second reservoirs.

A device wherein preferable said first reservoir has a predeterminedoptimal pressure regulation volume treatment interval and wherein saidpump is adapted to pump liquid from the first to the second reservoir tokeep said first reservoir within said regulation interval, when saidaneurysm expands and to pump liquid from said implantable member intosaid first reservoir.

A device preferable provides a pressure equal or less than the diastolicblood pressure of a treated patient.

A device preferable adapted to increase the pressure on the blood vesselwhen the aneurysm expands.

A device comprising a control device adapted to increase the pressure onthe blood vessel when the aneurysm expands more than a predeterminedvalue, preferable during a time period.

A control unit adapted to control the expansion of said aneurysm bycontrolling the pressure applied on the blood vessel when the aneurysmexpands.

A device preferable further comprising a sensor for sensing an expansionof the aneurysm.

A device preferable further comprising a volume control unit adapted todirectly or indirectly control the volume in the implantable memberbased on a signal generated by the sensor for controlling an expansionof the aneurysm, wherein normally said volume control unit controls thevolume in the implantable member based on a signal indicative of: flowof fluid from said implantable member or pressure in said fluid filledin said implantable member.

A device wherein the implantable member is divided into a plurality ofsub-reservoirs.

A device wherein the sub-reservoirs are provided axially along the bloodvessel or radially along the blood vessel.

A device wherein preferable at least one reservoir is located above saidaneurysm and one reservoir is located below said aneurysm.

A device further comprising a logic circuitry for determining when theaneurysm is expanding based on the signal from the sensor.

A device further comprising an electrical pulse generator adapted toprovide electrical signals for stimulation of the aneurysm wall viaelectrodes located on the inside of the implantable member.

A control unit adapted to vary to position of the electrical stimulationsignals for stimulation of the aneurysm.

A method of treating an aneurysm of a mammal patient by providing themedical device according to any feature disclosed herein, comprising thesteps of:

inserting a needle or a tube like instrument into the patient'sabdominal cavity,

using the needle or tube like instrument to fill a part of the patient'sbody with gas and thereby expanding said abdominal cavity,

placing at least two laparoscopic trocars in said cavity,

inserting a camera through one of the laparoscopic trocars into saidcavity,

inserting at least one dissecting tool through one of said at least twolaparoscopic trocars,

dissecting an area of an aneurysm of a blood vessel,

placing the device onto said the aneurysmic blood vessel, and adjustingthe pressure the device exerts onto said aneurysm.

An alternative method of treating an aneurysm of a mammal patient byproviding the medical device including any feature disclosed herein,comprising the steps of:

inserting a needle or a tube like instrument into the patient'sthoraxial cavity,

using the needle or tube like instrument to fill a part of the patient'sbody with gas and thereby expanding said thoraxial cavity,

placing at least two laparoscopic trocars in said cavity,

inserting a camera through one of the laparoscopic trocars into saidcavity,

inserting at least one dissecting tool through one of said at least twolaparoscopic trocars,

dissecting an area of an aneurysm of a blood vessel,

placing the device onto said the aneurysmic blood vessel, and

adjusting the pressure said device exerts onto said aneurysm.

An alternative method of treating an aneurysm of a mammal patient byproviding the medical device including any feature disclosed herein,said method comprising the steps of:

cutting the skin in the abdominal or thoraxial wall of said mammalpatient, dissecting an area of the aneurysm,

placing said device onto said aneurysm, and

starting the stimulation device and adapted to adjust adjust anyparameter related to said stimulation.

adjusting the pressure said device exerts onto said aneurysm.

adjusting the pressure said device exerts onto said aneurysm.

A computer program product comprising computer program segments thatwhen executed on a computer causes the computer to control the pressureapplied by an implantable member adapted to hold fluid and adapted to beplaced in connection with a blood vessel having an aneurysm. A digitalstorage medium comprising the computer program product.

Third Combination Embodiments Includes a Mechanical System PuttingPressure on the Aneurysm Including any Feature in any Combination,Comprising

A device for treating a vascular aneurysm of a human or mammal patientcomprising:

-   -   An implantable member adapted to be placed in connection with a        blood vessel having an aneurysm for providing a pressure from        outside the blood vessel, the device being adapted to be        adjusted postoperatively.

A device preferable adapted to prevent or reduce an expansion of saidaneurysm.

A device adapted to monitor an expansion of said aneurysm.

The device is preferable adjustable non-invasively.

A device adapted to perform self adjustments of the pressure appliedonto said aneurysm within a predetermined treatment interval.

A device comprising an control unit and a sensor, wherein the controlunit is adapted to control the pressure applied onto said aneurysm basedon said signal generated by the sensor.

A device, wherein the surface of the member facing the blood vessel isadapted to exercise pressure on the blood vessel.

A device, wherein the pressure on the blood vessel is mechanicallyexercised.

A, wherein the mechanically exercised pressure is controlledhydraulically.

A device, wherein mechanical pressure on the blood vessel is directly orindirectly exercised by a motor or a pump.

A, wherein the implantable member is generally cylindrical

A device, wherein the implantable member comprises a number of segmentsbeing individually adjustable.

A device, wherein the implantable member is a Y-shaped member

A device, wherein the implantable Y-shaped member is adapted to beplaced at the Aorta Bifurcation.

A pressure regulating system adapted to even out the difference inpressure in the implantable reservoir in the systolic and diastolicphase to reduce the differences or to achieve a substantially evenpressure affecting said aneurysm from the outside of said blood vessel.

A device, wherein the implantable member is an elastic member.

A device, wherein the elastic member is a band.

A device, wherein the elastic member is adapted to apply a pressure ontosaid aneurysm and has an expansion interval wherein the pressure appliedis substantially constant or within an interval for treating andreducing expansion of the aneurysm.

A device, wherein the implantable member is spring loaded.

A device according to claim 1, wherein the implantable member ishydraulically operated.

A device, wherein the implantable member is pneumatically operated

A device, wherein the implantable member is adapted to exert anessentially constant pressure or a pressure reducing the pressuredifference, caused by the changes in blood pressure in said bloodvessel, on the aneurysm.

A device, wherein the provided pressure is equal or less than thediastolic blood pressure of a treated patient.

A device further comprising a control unit adapted to increase thepressure on the blood vessel when the aneurysm expands.

A device comprising a control device adapted to increase the pressure onthe blood vessel when the aneurysm expands more than a predeterminedvalue.

A device comprising a control device adapted to increase the pressure onthe blood vessel when the aneurysm expands more than a predeterminedvalue during a time period.

A device, further comprising a sensor or a measuring device for sensingan expansion of the aneurysm.

A device, further comprising logic circuitry for determining when theaneurysm is expanding based on a signal from a sensor or measuringdevice.

A device, further comprising an electrical pulse generator adapted toprovide stimulation of the aneurysm wall via electrodes located on theinside of the implantable member.

A method of treating an aneurysm of a mammal patient by providing themedical device according to any feature disclosed herein, comprising thesteps of:

inserting a needle or a tube like instrument into the patient'sabdominal cavity,

using the needle or tube like instrument to fill a part of the patient'sbody with gas and thereby expanding said abdominal cavity,

placing at least two laparoscopic trocars in said cavity,

inserting a camera through one of the laparoscopic trocars into saidcavity,

inserting at least one dissecting tool through one of said at least twolaparoscopic trocars,

dissecting an area of an aneurysm of a blood vessel,

placing the device onto said the aneurysmic blood vessel, and adjustingthe pressure the device exerts onto said aneurysm.

An alternative method of treating an aneurysm of a mammal patient byproviding the medical device including any feature disclosed herein,comprising the steps of:

inserting a needle or a tube like instrument into the patient'sthoraxial cavity,

using the needle or tube like instrument to fill a part of the patient'sbody with gas and thereby expanding said thoraxial cavity,

placing at least two laparoscopic trocars in said cavity,

inserting a camera through one of the laparoscopic trocars into saidcavity,

inserting at least one dissecting tool through one of said at least twolaparoscopic trocars,

dissecting an area of an aneurysm of a blood vessel,

placing the device onto said the aneurysmic blood vessel, and

adjusting the pressure said device exerts onto said aneurysm.

An alternative method of treating an aneurysm of a mammal patient byproviding the medical device including any feature disclosed herein,said method comprising the steps of:

cutting the skin in the abdominal or thoraxial wall of said mammalpatient,

dissecting an area of the aneurysm,

placing said device onto said aneurysm, and

starting the stimulation device and adapted to adjust adjust anyparameter related to said stimulation.

adjusting the pressure said device exerts onto said aneurysm.

adjusting the pressure said device exerts onto said aneurysm.

A computer program product comprising computer program segments thatwhen executed on a computer causes the computer to control the pressureapplied by an implantable member adapted to be placed in connection witha blood vessel having an aneurysm.

A digital storage medium comprising the computer program product.

Fourth Combination Embodiments Includes a Monitoring/Sensor SystemPutting Pressure on the Aneurysm Including any Feature in anyCombination, Comprising

A device for monitoring an aneurysm of a human or mammal patientcomprising:

A sensor placed in relation to a wall portion of the aneurysm forgenerating a signal corresponding to a parameter related to the aneurysmor the treatment of the aneurism.

A device, wherein the parameter corresponds to the size of the aneurysm.

A device, wherein the parameter corresponds to the diameter of theaneurysm.

A device wherein the sensor is a gauge sensor.

A device wherein the parameter corresponds to a pressure.

A device wherein the pressure corresponds to a pressure from a hydrauliccuff provided around the aneurysm.

A device wherein the pressure corresponds to a pressure from amechanical implantable member provided around the aneurysm.

A device wherein the pressure corresponds to a pressure in a bloodvessel.

A device wherein the sensor is adapted to measure the pressure exertedon an implantable member provided around the aneurysm.

A device wherein the sensor is adapted to measure the volume of ahydraulic implantable member.

A method of treating an aneurysm of a mammal patient by providing themedical device, comprising the steps of:

inserting a needle or a tube like instrument into the patient'sabdominal cavity,

using the needle or tube like instrument to fill a part of the patient'sbody with gas and thereby expanding said abdominal cavity,

placing at least two laparoscopic trocars in said cavity,

inserting a camera through one of the laparoscopic trocars into saidcavity,

inserting at least one dissecting tool through one of said at least twolaparoscopic trocars,

dissecting an area of an aneurysm of a blood vessel,

placing the device onto said the aneurysmic blood vessel, and

monitoring the expansion of the aneurysm by measuring the expansion theaneurysm exerts onto the device.

A method of treating an aneurysm of a mammal patient by providing themedical device, comprising the steps of:

inserting a needle or a tube like instrument into the patient'sthoraxial cavity,

using the needle or tube like instrument to fill a part of the patient'sbody with gas and thereby expanding said thoraxial cavity,

placing at least two laparoscopic trocars in said cavity,

inserting a camera through one of the laparoscopic trocars into saidcavity,

inserting at least one dissecting tool through one of said at least twolaparoscopic trocars,

dissecting an area of an aneurysm of a blood vessel,

placing the device onto said the aneurysmic blood vessel, and

monitoring the expansion of the aneurysm by measuring the expansion theaneurysm exerts onto the device.

A method of treating an aneurysm of a mammal patient by providing themedical device, said method comprising the steps of:

cutting the skin in the abdominal or thoraxial wall of said mammalpatient,

dissecting an area of the aneurysm,

placing said device onto said aneurysm, and

monitoring the expansion of the aneurysm by measuring the expansion theaneurysm exerts onto the device.

A method of treating an aneurysm of a mammal patient by providing themedical device, said method comprising the steps of:

cutting the skin of said mammal patient,

dissecting an area of the aneurysm,

placing said device onto said aneurysm, and

monitoring the expansion of the aneurysm by measuring the expansion theaneurysm exerts onto the device.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will now be described in more detail by way ofnon-limiting examples and with reference to the accompanying drawings,in which:

FIG. 1 is general view of a human body having a device for treatinganeurysm implanted,

FIG. 2 is a view illustrating a device for treating aneurysm withassociated equipment,

FIG. 3 is a view illustrating a mechanical device for treating aneurysm,

FIG. 4 is a view illustrating a mechanical device for treating aneurysm,

FIG. 5 is a view illustrating a hydraulic device for treating aneurysm,

FIG. 6 is a view illustrating a hydraulic device for treating aneurysm,

FIG. 7 is a view illustrating a hydraulic device for treating aneurysm,

FIG. 8 is a view illustrating a stimulation device for treating avascular aneurysm of a human or mammal patient,

FIG. 9 is a view illustrating a sensor used when treating or monitoringa vascular aneurysm of a human or mammal patient,

FIG. 10 is a view from above of a device for treating aneurysm implantedaround a blood vessel,

FIG. 11 is a view of a device for treating aneurysm having a Y-shape,

FIG. 12 is a flowchart illustrating steps performed when implanting adevice for treating or monitoring an aneurysm in accordance with oneembodiment,

FIG. 12 is a flowchart illustrating steps performed when implanting adevice for treating or monitoring an aneurysm in accordance with oneembodiment,

FIG. 13 is a flowchart illustrating steps performed when implanting adevice for treating or monitoring an aneurysm in accordance with oneembodiment,

FIG. 14 is a flowchart illustrating steps performed when implanting adevice for treating or monitoring an aneurysm in accordance with oneembodiment, and

FIG. 15 is a flowchart illustrating steps performed when implanting adevice for treating or monitoring an aneurysm in accordance with oneembodiment.

FIG. 16 illustrates a system for treating a disease, wherein the systemincludes a device of the invention implanted in a patient.

FIGS. 17-31 schematically show various embodiments of the system forwirelessly powering the device shown in FIG. 16.

FIG. 32 is a schematic block diagram illustrating an arrangement forsupplying an accurate amount of energy used for the operation of thedevice shown in FIG. 16.

FIG. 33 schematically shows an embodiment of the system, in which thedevice is operated with wire bound energy.

FIG. 34 is a more detailed block diagram of an arrangement forcontrolling the transmission of wireless energy used for the operationof the device shown in FIG. 16.

FIG. 35 is a circuit for the arrangement shown in FIG. 34, according toa possible implementation example.

FIGS. 36-42 show various ways of arranging hydraulic or pneumaticpowering of a device implanted in a patient.

DETAILED DESCRIPTION

In FIG. 1 a general view of a human 100 having a member, in particular acuff 101, implanted for treating an aneurism is shown. In FIG. 1 thetreated aneurism is located on the aorta in the abdomen close to theY-bifurcation extending to the legs. The cuff 101 can be designed invarious ways but is generally formed as an implantable member adapted tobe placed in connection with a blood vessel having said vascularaneurysm, and adapted to exert a pressure on said aneurysm from theoutside of said blood vessel. In particular the pressure exerted on theblood vessel is essentially uniform from all direction and adapted tohinder the blood vessel to expand in all directions thereby acting toprevent the blood vessel from bursting. The pressure can in accordancewith one embodiment be essentially equal to or lower than the diastolicblood pressure of the treated patient. The cuff 101 can be made in anysuitable material such as an elastic material adapted for implantationin a human or mammal body.

The cuff 101 can exercise the pressure in a number of different ways. Inaccordance with one embodiment of the present invention the pressureapplied on the blood vessel can be mechanical and adjustable by means ofan adjustable screw or a similar means in order to apply a pressure onthe blood vessel. The cuff 101 can also be formed by a spring loadedmember and operated in a suitable manner such as hydraulically orpneumatically.

In FIG. 2 a cuff 101 in accordance with one embodiment of the presentinvention is shown in more detail. The cuff 101 comprises a number ofsegments 103 each adjustable and possible to tailor to fit a particularaneurism 102 of a blood vessel 104 to be treated. Each segment 103 canbe adjusted either as a whole or individually. The segments 103 can becontrolled and adjusted mechanically by an adjustable screw or similaror adapted to be filled with a fluid. For example, the segments can beprovided axially along the blood vessel and also radially along theblood vessel forming a matrix of sub-segments that constitutes the cuff101. In particular one segment can be located above and one below theaneurysm along the blood vessel.

The adjustment can be controlled by an electronic control unit 105adapted to receive and transmit signals from a transmitter/receiver 106located outside the body of a treated patient. The electronic controlunit can also comprise a chargeable battery 111 chargeable from theoutside by an external charger unit 112. The electronic control unit cancomprise an electrical pulse generator 109 for generating electricalpulses as is described in more detail below.

The electronic control unit 105, such as a microprocessor or a MCU or aFPGA or a ASIC and can further be connected to or comprise a hydraulicpump 110 associated with a reservoir 115 containing of a fluid used toregulate the pressure of the cuff 101. The pump is thus adapted to pumpthe hydraulic fluid in or out from the cuff 101 in order to adjust thepressure applied in the aneurism. The control mechanism used for keepingthe pressure in the cuff 101 can comprise a pressure tank 117.

In a preferred embodiment the pressure tank 117 is adapted to be able tochange its volume still keeping substantially the same pressure, thuskeeping the same pressure onto the aneurysm although some expansion ofsize of the aneurysm may occur. However, if the expansion goes too farthe pressure tank may come out of range to keep the pressure constantand with some kind of volume detection in the pressure tank the pump 110is then able to move fluid out from the pressure tank into the reservoir115 to again be within pressure range in the pressure tank. The pressuretank is also able to even out the systolic pulses supplied to theaneurysmic wall.

The cuff 101 can be shaped in any desirable form to enable treatment ofan aneurism wherever it is located. In accordance with one embodimentthe cuff 101 is provided with at least one sensor 107 adapted to sensethe pressure from the blood vessel that the cuff is surrounding.

The sensor(s) 107 used to generate a signal indicative of one or manyparameters related to the aneurism and the device 101 used for treatingthe aneurism can for example be a gauge sensor. The sensor 107 can beadapted to generate sensor signals used for monitoring parametersincluding but not limited to the pressure in a hydraulic cuff, thepressure of a mechanical cuff, the pressure of a pneumatic cuff, thepressure in a blood vessel, the shape of the blood vessel in particulara parameter related to the diameter of the aneurysm.

An alternative or complement to the remote placed transmitter 106 is aswitch (part of 105), preferable subcutaneously placed, such a switchmay be mechanical or electrical, such as a microprocessor or a MCU or aFPGA or a ASIC, or the switch may comprise a small hydraulic controlreservoir.

The restriction device may comprise any hydraulic device or mechanicaldevice or stimulation device alone or monitoring/sensor device in anycombination as described in the present application. The stimulationdevice may comprise both thermal stimulation or electrical stimulation.If a hydraulic system is used the hydraulic pump may in a systemcomprise an injection port (part of 110) for the injection of hydraulicfluid, preferable for calibration of hydraulic fluid. A subcutaneouslyplace switch may also be used as well as an feed back alarm systemconnected to the sensor/monitoring system.

Although the device has specific placements on the drawings it should beunderstood that the placement might vary.

Any combination of features or embodiments may comprise from any sourcewithin this application.

Any embodiment in any combination that is disclosed in this application,specially, but not limited to, in FIG. 1-42, may be used.

In FIG. 3 a view illustrating a mechanical cuff 101 is shown. The cuffcan for example comprise an elastic material 301 kept in place by asuitable compressing device. The cuff 101 in accordance with oneembodiment of the present invention comprises an elastic material in theform of a number of gel filled pads 301. The pads 301 can be shaped in asuitable manner and in particular formed to absorb the geometrical shapeof the aneurysm. This can for example be achieved by providing pads withdifferent tilting angles. The elastic material 301 can be kept in placeby at least one adjustable fastening member 303. The fastening member303 can for example be adjusted by a screw 305 or a similar device. Byadjusting the fastening member 303 the pressure applied on the aneurysmcan be controlled.

In FIG. 4, a view illustrating a mechanical cuff 101 is shown. The cuffcan for example comprise an elastic band 401. The band 401 can beadjusted by an adjustor 403 to provide a higher or smaller pressure onthe aneurysm.

In FIG. 5, a view illustrating a hydraulic cuff 101 is shown. The cuffcan for example comprise implantable member 501 adapted to hold fluid.The member 501 is adapted to be placed in connection with a blood vesselhaving an aneurysm. The member can exercise a pressure on the aneurysmthe blood vessel in response to the conditions of the fluid of themember 501. By filling the member with a fluid pressure can be appliedonto the aneurysm in order to prevent or reduce an expansion theaneurysm when implanted in a patient thereby enabling postoperativetreatment of the aneurysm. Further the treatment can be adjustedpostoperatively by regulating the pressure using an implanted pressureregulator 503. The pressure regulator can for example be formed by apressure tank 503 implanted in the patient interconnected via a hose 504with the member 501. The pressure tank can comprise an expandablereservoir 505 for storing superfluous fluid.

In FIG. 6, a view illustrating a hydraulic cuff 101 is shown. The cuffcan for example comprise implantable member 601 adapted to hold fluid.The member 601 is adapted to be placed in connection with a blood vesselhaving an aneurysm. The member can exercise a pressure on the aneurysmthe blood vessel in response to the conditions of the fluid of themember 601. By filling the member with a fluid pressure can be appliedonto the aneurysm in order to prevent or reduce an expansion theaneurysm when implanted in a patient thereby enabling postoperativetreatment of the aneurysm. Further the treatment can be adjustedpostoperatively by regulating the pressure using an implanted pressureregulator 603. The pressure regulator can for example be formed by aspring loaded tank 603 implanted in the patient interconnected via ahose 604 with the member 601. The spring 606 used to control thepressure of the tank and thereby indirectly the pressure applied by thecuff 101 on the aneurysm can be an adjustable spring in order to controlthe pressure.

In FIG. 7, a view illustrating a hydraulic cuff 101 is shown. The cuffcan for example comprise implantable member 701 adapted to hold fluid.The member 601 is adapted to be placed in connection with a blood vesselhaving an aneurysm. The member can exercise a pressure on the aneurysmthe blood vessel in response to the conditions of the fluid of themember 701. By filling the member with a fluid pressure can be appliedonto the aneurysm in order to prevent or reduce an expansion theaneurysm when implanted in a patient thereby enabling postoperativetreatment of the aneurysm. Further the treatment can be adjustedpostoperatively by regulating the pressure using an implanted pressureregulator 703. The pressure regulator can for example be formed by apump 703 implanted in the patient on a hose 704 interconnecting a tank705 with the member 701. The pump 703 is used to control the pressure ofthe member 703 by pumping fluid in and out of the member 701 and therebycontrolling the pressure applied by the cuff 101 on the aneurysm.

By sensing the pressure from the blood vessel the cuff can be controlledto apply a correct pressure on the blood vessel thereby keeping the formof the blood vessel essentially constant. For example the pressure mayvary over time as a result of changes in the wall of the blood vessel ofsurrounding tissue. Also the pressure will change as a function of thephase in which the heart is working. In other words the pressure will bedifferent in a systolic phase as compared to a diastolic phase. By usinga pressure sensor the pressure applied by the cuff 101 can be adapted toreact to changes in the sensed pressure and apply a correspondingcounter pressure. The sensor signals generated by the sensor(s) 107 ofthe cuff can also be used to trigger an alarm in response to the sensorsignal indicating an expansion of the aneurism. In response to an alarmsignal being generated the cuff can be automatically controlled toexercise a counter pressure on the blood vessel to counter or limit theexpansion of the aneurism.

In yet another embodiment, electrodes 108 can be provided in the cuff.The electrodes can be connected to the electrical pulse generator, whichis adapted to generate electrical pulses for stimulating the wall of theaneurism. The purpose of the electrical stimulation is to increase thetonus of the wall of the aneurism.

In FIG. 8, a stimulation device 801 for treating a vascular aneurysm ofa human or mammal patient is shown. The device 801 comprises at leastone implantable electrode 803 adapted to be placed in close connectionto the aneurysm. The electrode is adapted to provide an electricalstimulation pulse on a wall portion of the aneurysm. The electricalstimulation pulse can for example be generated by a pulse generator 805.The pulse generator can be implanted in the patient.

In accordance with one embodiment the electrical stimulation device usedfor treating a vascular aneurysm of a human or mammal patient isconnected to electrodes adapted to stimulate the wall of the aneurism atmultiple stimulation points. The multiple stimulation groups may furtherbe organized in different stimulation groups which can stimulatedindependently of each other. In accordance with one embodiment theelectrical stimulation is performed with positive and or negativevoltage stimulation pulses. In one embodiment the current used forstimulation of the aneurysm wall is kept essentially constant.

The sequence of electrical pulses used to stimulation the wall of theaneurysm can be applied with a predetermined periodicity having periodsof no stimulation therein between during which periods withoutstimulation the wall of the aneurysm is allowed to rest. The electricalstimulation signal can also be Pulse Width Modulated to control theenergy applied. In accordance with one embodiment the electricalstimulation is applied during the systolic phase to increase the tonusof the wall of the aneurysm. The systolic phase can be detected by thesensors 107 used to sense the pressure of the aneurysm as describedabove.

In accordance with one embodiment the stimulation can be controlled tobe applied with a temporarily increased intensity and position duringemergency situations when the aneurysm is detected to rapidly expands,to limit the expansion of said aneurysm.

In order to provide input for controlling the pressure and or to monitorthe aneurysm a device 107 can be provided. In FIG. 9 a view illustratinga sensor 901 used when treating or monitoring a vascular aneurysm of ahuman or mammal patient is shown. The sensor 901 is placed in relationto a wall portion of the aneurysm for generating a signal correspondingto a parameter related to the aneurysm or the treatment of the aneurism.The signal generated by the sensor can be a signal corresponding to thesize of the aneurysm and is accessible via a signal output 903. Forexample the signal can be indicative of the diameter of the aneurysm. Inaccordance with one embodiment of the he sensor is a gauge sensor. Thesensor 901 can also be adapted to generate any output related tomonitoring or treatment of the aneurysm. For example the sensor can beadapted to sense the resistance, capacitance, pressure, volumeextension, flexure of a member in contact with the aneurysm.

The shape of the cuff 101 can as stated above be tailor made to suit thelocation where an aneurysm is to be treated. In FIG. 10, a cuff 101 isseen from above in a direction aligned with a treated blood vessel. Ascan be seen in FIG. 3 each segment 3 can be sub-divided into a number ofsub segments 103 a, 103 b . . . together forming a closed loop aroundthe treated aneurysm. In case the aneurysm is located in the aortabifurcation region the cuff 101 can be Y-shaped as is shown in FIG. 11.

The device as described herein can be implanted in a patient using somesuitable surgical procedure as depicted in FIG. 12. For example, thedevice can be implanted by inserting a needle or a tube like instrumentinto the patient's abdominal cavity, step 1201. Next in a step 1203 apart of the patient's body with gas using the needle or tube likeinstrument thereby expanding said abdominal cavity. Next in a step 1205at least two laparoscopic trocars are placed in the cavity. Thereupon ina step 1207 a camera is inserted through one of the laparoscopic trocarsinto the cavity. Next in a step 1209 at least one dissecting tool isinserted through one of said at least two laparoscopic trocars. An areaof an aneurysm of a blood vessel is then dissected in a step 1211. Thedevice is then placed onto the aneurysmic blood vessel in a step 1213,and the pressure that the device exerts onto the aneurysm is adjusted ina step 1215.

In accordance with one embodiment of the present invention the devicecan be implanted by a procedure depicted in FIG. 13. First in a step1301 a needle or a tube like instrument is inserted into the patient'sthoraxial cavity. Next, in a step 1303 a part of the patient's body withgas using the needle or tube like instrument to fill and therebyexpanding the thoraxial cavity. Thereupon at least two laparoscopictrocars are placed in said cavity in a step 1305 Thereupon in a step1307 a camera is inserted through one of the laparoscopic trocars intothe cavity. Next in a step 1309 at least one dissecting tool is insertedthrough one of said at least two laparoscopic trocars. An area of ananeurysm of a blood vessel is then dissected in a step 1311. The deviceis then placed onto the aneurysmic blood vessel in a step 1313, and thepressure that the device exerts onto the aneurysm is adjusted in a step1315.

In accordance with one embodiment of the present invention the devicecan be implanted by a procedure depicted in FIG. 14. First in a step1401, the skin in the abdominal or thoraxial wall of the mammal patientis cut. Next, in a step 1403 an area of the aneurysm is dissected. Next,the device is then placed onto the aneurysmic blood vessel in a step1405, and the pressure that the device exerts onto the aneurysm isadjusted in a step 1407.

In accordance with one embodiment of the present invention the devicecan be implanted by a procedure depicted in FIG. 15. First in a step1501, the skin of the mammal patient is cut. Next, in a step 1503 anarea of the aneurysm is dissected. Next, the device is then placed ontothe aneurysmic blood vessel in a step 1505, and the pressure that thedevice exerts onto the aneurysm is adjusted in a step 1507.

FIG. 16 illustrates a system for treating a disease comprising a device10 of the present invention placed in the abdomen of a patient. Animplanted energy-transforming device 3020 is adapted to supply energyconsuming components of the device with energy via a power supply line3030. An external energy-transmission device 3040 for non-invasivelyenergizing the device 10 transmits energy by at least one wirelessenergy signal. The implanted energy-transforming device 10020 transformsenergy from the wireless energy signal into electric energy which issupplied via the power supply line 3030.

In one embodiment at least one battery may be a part of or replace theenergy transforming device 3020 to supply energy to the device 10 over apower supply line 3030. In one embodiment the battery is notrechargeable. In an alternative embodiment the battery is rechargeable.The battery supply may of course be placed both remote to andincorporated in the device.

The wireless energy signal may include a wave signal selected from thefollowing: a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal and a gammaradiation signal. Alternatively, the wireless energy signal may includean electric or magnetic field, or a combined electric and magneticfield.

The wireless energy-transmission device 3040 may transmit a carriersignal for carrying the wireless energy signal. Such a carrier signalmay include digital, analogue or a combination of digital and analoguesignals. In this case, the wireless energy signal includes an analogueor a digital signal, or a combination of an analogue and digital signal.

Generally speaking, the energy-transforming device 3020 is provided fortransforming wireless energy of a first form transmitted by theenergy-transmission device 3040 into energy of a second form, whichtypically is different from the energy of the first form. The implanteddevice 10 is operable in response to the energy of the second form. Theenergy-transforming device 3020 may directly power the device with thesecond form energy, as the energy-transforming device 3020 transformsthe first form energy transmitted by the energy-transmission device 3040into the second form energy. The system may further include animplantable accumulator, wherein the second form energy is used at leastpartly to charge the accumulator.

Alternatively, the wireless energy transmitted by theenergy-transmission device 3040 may be used to directly power thedevice, as the wireless energy is being transmitted by theenergy-transmission device 3040. Where the system comprises an operationdevice for operating the device, as will be described below, thewireless energy transmitted by the energy-transmission device 1004 maybe used to directly power the operation device to create kinetic energyfor the operation of the device.

The wireless energy of the first form may comprise sound waves and theenergy-transforming device 3020 may include a piezo-electric element fortransforming the sound waves into electric energy. The energy of thesecond form may comprise electric energy in the form of a direct currentor pulsating direct current, or a combination of a direct current andpulsating direct current, or an alternating current or a combination ofa direct and alternating current. Normally, the device compriseselectric components that are energized with electrical energy. Otherimplantable electric components of the system may be at least onevoltage level guard or at least one constant current guard connectedwith the electric components of the device.

Optionally, one of the energy of the first form and the energy of thesecond form may comprise magnetic energy, kinetic energy, sound energy,chemical energy, radiant energy, electromagnetic energy, photo energy,nuclear energy or thermal energy. Preferably, one of the energy of thefirst form and the energy of the second form is non-magnetic,non-kinetic, non-chemical, non-sonic, non-nuclear or non-thermal.

The energy-transmission device may be controlled from outside thepatient's body to release electromagnetic wireless energy, and thereleased electromagnetic wireless energy is used for operating thedevice. Alternatively, the energy-transmission device is controlled fromoutside the patient's body to release non-magnetic wireless energy, andthe released non-magnetic wireless energy is used for operating thedevice.

The external energy-transmission device 3040 also includes a wirelessremote control having an external signal transmitter for transmitting awireless control signal for non-invasively controlling the device. Thecontrol signal is received by an implanted signal receiver which may beincorporated in the implanted energy-transforming device 3020 or beseparate there from.

The wireless control signal may include a frequency, amplitude, or phasemodulated signal or a combination thereof. Alternatively, the wirelesscontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal. Alternatively, thewireless control signal comprises an electric or magnetic field, or acombined electric and magnetic field.

The wireless remote control may transmit a carrier signal for carryingthe wireless control signal. Such a carrier signal may include digital,analogue or a combination of digital and analogue signals. Where thecontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal, the wireless remotecontrol preferably transmits an electromagnetic carrier wave signal forcarrying the digital or analogue control signals.

FIG. 17 illustrates the system of FIG. 16 in the form of a moregeneralized block diagram showing the device 10, the energy-transformingdevice 3020 powering the device 10 via power supply line 3030, and theexternal energy-transmission device 3040, The patient's skin 3050,generally shown by a vertical line, separates the interior of thepatient to the right of the line from the exterior to the left of theline.

FIG. 18 shows an embodiment of the invention identical to that of FIG.17, except that a reversing device in the form of an electric switch3060 operable for example by polarized energy also is implanted in thepatient for reversing the device 10. When the switch is operated bypolarized energy the wireless remote control of the externalenergy-transmission device 3040 transmits a wireless signal that carriespolarized energy and the implanted energy-transforming device 3020transforms the wireless polarized energy into a polarized current foroperating the electric switch 3060. When the polarity of the current isshifted by the implanted energy-transforming device 3020 the electricswitch 3060 reverses the function performed by the device 10.

FIG. 19 shows an embodiment of the invention identical to that of FIG.17, except that an operation device 3070 implanted in the patient foroperating the device 10 is provided between the implantedenergy-transforming device 3020 and the device 10. This operation devicecan be in the form of a motor 3070, such as an electric servomotor. Themotor 3070 is powered with energy from the implanted energy-transformingdevice 3020, as the remote control of the external energy-transmissiondevice 3040 transmits a wireless signal to the receiver of the implantedenergy-transforming device 3020.

FIG. 20 shows an embodiment of the invention identical to that of FIG.17, except that it also comprises an operation device is in the form ofan assembly 3080 including a motor/pump unit 3090 and a fluid reservoir3100 is implanted in the patient. In this case the device 10 ishydraulically operated, i.e. hydraulic fluid is pumped by the motor/pumpunit 3090 from the fluid reservoir 3100 through a conduit 3110 to thedevice 10 to operate the device, and hydraulic fluid is pumped by themotor/pump unit 3090 back from the device 10 to the fluid reservoir 3100to return the device to a starting position. The implantedenergy-transforming device 1002 transforms wireless energy into acurrent, for example a polarized current, for powering the motor/pumpunit 1009 via an electric power supply line 3120.

Instead of a hydraulically operated device 10, it is also envisaged thatthe operation device comprises a pneumatic operation device. In thiscase, the hydraulic fluid can be pressurized air to be used forregulation and the fluid reservoir is replaced by an air chamber.

In all of these embodiments the energy-transforming device 3020 mayinclude a rechargeable accumulator like a battery or a capacitor to becharged by the wireless energy and supplies energy for any energyconsuming part of the system.

As an alternative, the wireless remote control described above may bereplaced by manual control of any implanted part to make contact with bythe patient's hand most likely indirect, for example a press buttonplaced under the skin.

FIG. 21 shows an embodiment of the invention comprising the externalenergy-transmission device 3040 with its wireless remote control, thedevice 10, in this case hydraulically operated, and the implantedenergy-transforming device 3020, and further comprising a hydraulicfluid reservoir 3130, a motor/pump unit 3090 and an reversing device inthe form of a hydraulic valve shifting device 3140, all implanted in thepatient. Of course the hydraulic operation could easily be performed byjust changing the pumping direction and the hydraulic valve maytherefore be omitted. The remote control may be a device separated fromthe external energy-transmission device or included in the same. Themotor of the motor/pump unit 3090 is an electric motor. In response to acontrol signal from the wireless remote control of the externalenergy-transmission device 3040, the implanted energy-transformingdevice 3020 powers the motor/pump unit 3090 with energy from the energycarried by the control signal, whereby the motor/pump unit 3090distributes hydraulic fluid between the hydraulic fluid reservoir 3130and the device 10. The remote control of the externalenergy-transmission device 3040 controls the hydraulic valve shiftingdevice 3140 to shift the hydraulic fluid flow direction between onedirection in which the fluid is pumped by the motor/pump unit 3090 fromthe hydraulic fluid reservoir 3130 to the device 10 to operate thedevice, and another opposite direction in which the fluid is pumped bythe motor/pump unit 3090 back from the device 10 to the hydraulic fluidreservoir 3130 to return the device to a starting position.

FIG. 22 shows an embodiment of the invention comprising the externalenergy-transmission device 1004 with its wireless remote control, thedevice 10, the implanted energy-transforming device 3020, an implantedinternal control unit 3150 controlled by the wireless remote control ofthe external energy-transmission device 3040, an implanted accumulator3160 and an implanted capacitor 3170. The internal control unit 1015arranges storage of electric energy received from the implantedenergy-transforming device 3020 in the accumulator 3160, which suppliesenergy to the device 10. In response to a control signal from thewireless remote control of the external energy-transmission device 3040,the internal control unit 3150 either releases electric energy from theaccumulator 3160 and transfers the released energy via power lines 3180and 3190, or directly transfers electric energy from the implantedenergy-transforming device 3020 via a power line 3200, the capacitor3170, which stabilizes the electric current, a power line 3210 and thepower line 3190, for the operation of the device 10.

The internal control unit is preferably programmable from outside thepatient's body. In a preferred embodiment, the internal control unit isprogrammed to regulate the device 10 according to a pre-programmedtime-schedule or to input from any sensor sensing any possible physicalparameter of the patient or any functional parameter of the system.

In accordance with an alternative, the capacitor 3170 in the embodimentof FIG. 7 may be omitted. In accordance with another alternative, theaccumulator 3160 in this embodiment may be omitted.

FIG. 23 shows an embodiment of the invention identical to that of FIG.17, except that a battery 3220 for supplying energy for the operation ofthe device 10 and an electric switch 3230 for switching the operation ofthe device 10 also are implanted in the patient. The electric switch3230 may be controlled by the remote control and may also be operated bythe energy supplied by the implanted energy-transforming device 3020 toswitch from an off mode, in which the battery 3220 is not in use, to anon mode, in which the battery 3220 supplies energy for the operation ofthe device 10.

FIG. 24 shows an embodiment of the invention identical to that of FIG.23, except that an internal control unit 3150 controllable by thewireless remote control of the external energy-transmission device 3040also is implanted in the patient. In this case, the electric switch 3230is operated by the energy supplied by the implanted energy-transformingdevice 3020 to switch from an off mode, in which the wireless remotecontrol is prevented from controlling the internal control unit 3150 andthe battery is not in use, to a standby mode, in which the remotecontrol is permitted to control the internal control unit 3150 torelease electric energy from the battery 3220 for the operation of thedevice 10.

FIG. 25 shows an embodiment of the invention identical to that of FIG.24, except that an accumulator 3160 is substituted for the battery 3220and the implanted components are interconnected differently. In thiscase, the accumulator 3160 stores energy from the implantedenergy-transforming device 3020. In response to a control signal fromthe wireless remote control of the external energy-transmission device3040, the internal control unit 3150 controls the electric switch 3230to switch from an off mode, in which the accumulator 3160 is not in use,to an on mode, in which the accumulator 3160 supplies energy for theoperation of the device 10. The accumulator may be combined with orreplaced by a capacitor.

FIG. 26 shows an embodiment of the invention identical to that of FIG.25, except that a battery 3220 also is implanted in the patient and theimplanted components are interconnected differently. In response to acontrol signal from the wireless remote control of the externalenergy-transmission device 3040, the internal control unit 3150 controlsthe accumulator 3160 to deliver energy for operating the electric switch3230 to switch from an off mode, in which the battery 3220 is not inuse, to an on mode, in which the battery 3220 supplies electric energyfor the operation of the device 10.

Alternatively, the electric switch 3230 may be operated by energysupplied by the accumulator 3160 to switch from an off mode, in whichthe wireless remote control is prevented from controlling the battery3220 to supply electric energy and is not in use, to a standby mode, inwhich the wireless remote control is permitted to control the battery3220 to supply electric energy for the operation of the device 10.

It should be understood that the switch 3230 and all other switches inthis application should be interpreted in its broadest embodiment. Thismeans a transistor, MCU, MCPU, ASIC, FPGA or a DA converter or any otherelectronic component or circuit that may switch the power on and off.Preferably the switch is controlled from outside the body, oralternatively by an implanted internal control unit.

FIG. 27 shows an embodiment of the invention identical to that of FIG.23, except that a motor 3070, a mechanical reversing device in the formof a gear box 3240, and an internal control unit 3150 for controllingthe gear box 3240 also are implanted in the patient. The internalcontrol unit 3150 controls the gear box 3240 to reverse the functionperformed by the device 10 (mechanically operated). Even simpler is toswitch the direction of the motor electronically. The gear boxinterpreted in its broadest embodiment may stand for a servo arrangementsaving force for the operation device in favor of longer stroke to act.

FIG. 28 shows an embodiment of the invention identical to that of FIG.24 except that the implanted components are interconnected differently.Thus, in this case the internal control unit 3150 is powered by thebattery 3220 when the accumulator 3160, suitably a capacitor, activatesthe electric switch 3230 to switch to an on mode. When the electricswitch 3230 is in its on mode the internal control unit 3150 ispermitted to control the battery 3220 to supply, or not supply, energyfor the operation of the device 10.

FIG. 29 schematically shows conceivable combinations of implantedcomponents of the device for achieving various communication options.Basically, there are the device 10, the internal control unit 3150,motor or pump unit 3090, and the external energy-transmission device3040 including the external wireless remote control. As alreadydescribed above the wireless remote control transmits a control signalwhich is received by the internal control unit 3150, which in turncontrols the various implanted components of the device.

A feedback device, preferably comprising a sensor or measuring device3250, may be implanted in the patient for sensing a physical parameterof the patient. The physical parameter may be at least one selected fromthe group consisting of pressure, volume, diameter, stretching,elongation, extension, movement, bending, elasticity, musclecontraction, nerve impulse, body temperature, blood pressure, bloodflow, heartbeats and breathing. The sensor may sense any of the abovephysical parameters. For example, the sensor may be a pressure ormotility sensor. Alternatively, the sensor 3250 may be arranged to sensea functional parameter. The functional parameter may be correlated tothe transfer of energy for charging an implanted energy source and mayfurther include at least one selected from the group of parametersconsisting of electricity, any electrical parameter, pressure, volume,diameter, stretch, elongation, extension, movement, bending, elasticity,temperature and flow.

The feedback may be sent to the internal control unit or out to anexternal control unit preferably via the internal control unit. Feedbackmay be sent out from the body via the energy transfer system or aseparate communication system with receiver and transmitters.

The internal control unit 3150, or alternatively the external wirelessremote control of the external energy-transmission device 3040, maycontrol the device 10 in response to signals from the sensor 3250. Atransceiver may be combined with the sensor 3250 for sending informationon the sensed physical parameter to the external wireless remotecontrol. The wireless remote control may comprise a signal transmitteror transceiver and the internal control unit 3150 may comprise a signalreceiver or transceiver. Alternatively, the wireless remote control maycomprise a signal receiver or transceiver and the internal control unit3150 may comprise a signal transmitter or transceiver. The abovetransceivers, transmitters and receivers may be used for sendinginformation or data related to the device 10 from inside the patientsbody to the outside thereof.

Where the motor/pump unit 3090 and battery 3220 for powering themotor/pump unit 3090 are implanted, information related to the chargingof the battery 3220 may be fed back. To be more precise, when charging abattery or accumulator with energy feed back information related to saidcharging process is sent and the energy supply is changed accordingly.

FIG. 30 shows an alternative embodiment wherein the device 10 isregulated from outside the patient's body. The system 3000 comprises abattery 3220 connected to the device 10 via a subcutaneous electricswitch 3260. Thus, the regulation of the device 10 is performednon-invasively by manually pressing the subcutaneous switch, whereby theoperation of the device 10 is switched on and off. It will beappreciated that the shown embodiment is a simplification and thatadditional components, such as an internal control unit or any otherpart disclosed in the present application can be added to the system.Two subcutaneous switches may also be used. In the preferred embodimentone implanted switch sends information to the internal control unit toperform a certain predetermined performance and when the patient pressthe switch again the performance is reversed.

FIG. 31 shows an alternative embodiment, wherein the system 3000comprises a hydraulic fluid reservoir 3130 hydraulically connected tothe device. Non-invasive regulation is performed by manually pressingthe hydraulic reservoir connected to the device.

The system may include an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator. The internal communicator feeds data related to the deviceor the patient to the external data communicator and/or the externaldata communicator feeds data to the internal data communicator.

FIG. 32 schematically illustrates an arrangement of the system that iscapable of sending information from inside the patient's body to theoutside thereof to give feedback information related to at least onefunctional parameter of the device or system, or related to a physicalparameter of the patient, in order to supply an accurate amount ofenergy to an implanted internal energy receiver 3020 connected toimplanted energy consuming components of the device 10. Such an energyreceiver 3020 may include an energy source and/or an energy-transformingdevice. Briefly described, wireless energy is transmitted from anexternal energy source 3040 a located outside the patient and isreceived by the internal energy receiver 3020 located inside thepatient. The internal energy receiver is adapted to directly orindirectly supply received energy to the energy consuming components ofthe device 10 via a switch 3260. An energy balance is determined betweenthe energy received by the internal energy receiver 3020 and the energyused for the device 10, and the transmission of wireless energy is thencontrolled based on the determined energy balance. The energy balancethus provides an accurate indication of the correct amount of energyneeded, which is sufficient to operate the device 10 properly, butwithout causing undue temperature rise.

In FIG. 32 the patient's skin is indicated by a vertical line 3050.Here, the energy receiver comprises an energy-transforming device 1002located inside the patient, preferably just beneath the patient's skin3050. Generally speaking, the implanted energy-transforming device 1002may be placed in the abdomen, thorax, muscle fascia (e.g. in theabdominal wall), subcutaneously, or at any other suitable location. Theimplanted energy-transforming device 3020 is adapted to receive wirelessenergy E transmitted from the external energy-source 3040 a provided inan external energy-transmission device 3040 located outside thepatient's skin 3050 in the vicinity of the implanted energy-transformingdevice 3020.

As is well known in the art, the wireless energy E may generally betransferred by means of any suitable Transcutaneous Energy Transfer(TET) device, such as a device including a primary coil arranged in theexternal energy source 1004 a and an adjacent secondary coil arranged inthe implanted energy-transforming device 3020. When an electric currentis fed through the primary coil, energy in the form of a voltage isinduced in the secondary coil which can be used to power the implantedenergy consuming components of the device, e.g. after storing theincoming energy in an implanted energy source, such as a rechargeablebattery or a capacitor. However, the present invention is generally notlimited to any particular energy transfer technique, TET devices orenergy sources, and any kind of wireless energy may be used.

The amount of energy received by the implanted energy receiver may becompared with the energy used by the implanted components of the device.The term “energy used” is then understood to include also energy storedby implanted components of the device. A control device includes anexternal control unit 3040 b that controls the external energy source3040 a based on the determined energy balance to regulate the amount oftransferred energy. In order to transfer the correct amount of energy,the energy balance and the required amount of energy is determined bymeans of a determination device including an implanted internal controlunit 3150 connected between the switch 3260 and the device 10. Theinternal control unit 3150 may thus be arranged to receive variousmeasurements obtained by suitable sensors or the like, not shown,measuring certain characteristics of the device 10, somehow reflectingthe required amount of energy needed for proper operation of the device10. Moreover, the current condition of the patient may also be detectedby means of suitable measuring devices or sensors, in order to provideparameters reflecting the patient's condition. Hence, suchcharacteristics and/or parameters may be related to the current state ofthe device 10, such as power consumption, operational mode andtemperature, as well as the patient's condition reflected by parameterssuch as; body temperature, blood pressure, heartbeats and breathing.Other kinds of physical parameters of the patient and functionalparameters of the device are described elsewhere.

Furthermore, an energy source in the form of an accumulator 3160 mayoptionally be connected to the implanted energy-transforming device 3020via the control unit 3150 for accumulating received energy for later useby the device 10. Alternatively or additionally, characteristics of suchan accumulator, also reflecting the required amount of energy, may bemeasured as well. The accumulator may be replaced by a rechargeablebattery, and the measured characteristics may be related to the currentstate of the battery, any electrical parameter such as energyconsumption voltage, temperature, etc. In order to provide sufficientvoltage and current to the device 10, and also to avoid excessiveheating, it is clearly understood that the battery should be chargedoptimally by receiving a correct amount of energy from the implantedenergy-transforming device 3020, i.e. not too little or too much. Theaccumulator may also be a capacitor with corresponding characteristics.

For example, battery characteristics may be measured on a regular basisto determine the current state of the battery, which then may be storedas state information in a suitable storage means in the internal controlunit 3150. Thus, whenever new measurements are made, the stored batterystate information can be updated accordingly. In this way, the state ofthe battery can be “calibrated” by transferring a correct amount ofenergy, so as to maintain the battery in an optimal condition.

Thus, the internal control unit 3150 of the determination device isadapted to determine the energy balance and/or the currently requiredamount of energy, (either energy per time unit or accumulated energy)based on measurements made by the above-mentioned sensors or measuringdevices of the device 10, or the patient, or an implanted energy sourceif used, or any combination thereof. The internal control unit 3150 isfurther connected to an internal signal transmitter 3270, arranged totransmit a control signal reflecting the determined required amount ofenergy, to an external signal receiver 3040 c connected to the externalcontrol unit 3040 b. The amount of energy transmitted from the externalenergy source 3040 a may then be regulated in response to the receivedcontrol signal.

Alternatively, the determination device may include the external controlunit 3040 b. In this alternative, sensor measurements can be transmitteddirectly to the external control unit 3040 b wherein the energy balanceand/or the currently required amount of energy can be determined by theexternal control unit 3040 b, thus integrating the above-describedfunction of the internal control unit 3150 in the external control unit3040 b. In that case, the internal control unit 3150 can be omitted andthe sensor measurements are supplied directly to the internal signaltransmitter 3270 which sends the measurements over to the externalsignal receiver 3040 c and the external control unit 3040 b. The energybalance and the currently required amount of energy can then bedetermined by the external control unit 3040 b based on those sensormeasurements.

Hence, the present solution according to the arrangement of FIG. 32employs the feed back of information indicating the required energy,which is more efficient than previous solutions because it is based onthe actual use of energy that is compared to the received energy, e.g.with respect to the amount of energy, the energy difference, or theenergy receiving rate as compared to the energy rate used by implantedenergy consuming components of the device. The device may use thereceived energy either for consuming or for storing the energy in animplanted energy source or the like. The different parameters discussedabove would thus be used if relevant and needed and then as a tool fordetermining the actual energy balance. However, such parameters may alsobe needed per se for any actions taken internally to specificallyoperate the device.

The internal signal transmitter 3270 and the external signal receiver3040 c may be implemented as separate units using suitable signaltransfer means, such as radio, IR (Infrared) or ultrasonic signals.Alternatively, the internal signal transmitter 3270 and the externalsignal receiver 3040 c may be integrated in the implantedenergy-transforming device 3020 and the external energy source 3040 a,respectively, so as to convey control signals in a reverse directionrelative to the energy transfer, basically using the same transmissiontechnique. The control signals may be modulated with respect tofrequency, phase or amplitude.

Thus, the feedback information may be transferred either by a separatecommunication system including receivers and transmitters or may beintegrated in the energy system. In accordance with the presentinvention, such an integrated information feedback and energy systemcomprises an implantable internal energy receiver for receiving wirelessenergy, the energy receiver having an internal first coil and a firstelectronic circuit connected to the first coil, and an external energytransmitter for transmitting wireless energy, the energy transmitterhaving an external second coil and a second electronic circuit connectedto the second coil. The external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver. This system further comprises a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off. Inimplementing this system in the arrangement of FIG. 32, the switch 3260is either separate and controlled by the internal control unit 3150, orintegrated in the internal control unit 3150. It should be understoodthat the switch 3260 should be interpreted in its broadest embodiment.This means a transistor, MCU, MCPU, ASIC FPGA or a DA converter or anyother electronic component or circuit that may switch the power on andoff.

To conclude, the energy supply arrangement illustrated in FIG. 32 mayoperate basically in the following manner. The energy balance is firstdetermined by the internal control unit 3150 of the determinationdevice. A control signal reflecting the required amount of energy isalso created by the internal control unit 3150, and the control signalis transmitted from the internal signal transmitter 3270 to the externalsignal receiver 3040 c. Alternatively, the energy balance can bedetermined by the external control unit 3040 b instead depending on theimplementation, as mentioned above. In that case, the control signal maycarry measurement results from various sensors. The amount of energyemitted from the external energy source 1004 a can then be regulated bythe external control unit 3040 b, based on the determined energybalance, e.g. in response to the received control signal. This processmay be repeated intermittently at certain intervals during ongoingenergy transfer, or may be executed on a more or less continuous basisduring the energy transfer.

The amount of transferred energy can generally be regulated by adjustingvarious transmission parameters in the external energy source 3040 a,such as voltage, current, amplitude, wave frequency and pulsecharacteristics.

This system may also be used to obtain information about the couplingfactors between the coils in a TET system even to calibrate the systemboth to find an optimal place for the external coil in relation to theinternal coil and to optimize energy transfer. Simply comparing in thiscase the amount of energy transferred with the amount of energyreceived. For example if the external coil is moved the coupling factormay vary and correctly displayed movements could cause the external coilto find the optimal place for energy transfer. Preferably, the externalcoil is adapted to calibrate the amount of transferred energy to achievethe feedback information in the determination device, before thecoupling factor is maximized.

This coupling factor information may also be used as a feedback duringenergy transfer. In such a case, the energy system of the presentinvention comprises an implantable internal energy receiver forreceiving wireless energy, the energy receiver having an internal firstcoil and a first electronic circuit connected to the first coil, and anexternal energy transmitter for transmitting wireless energy, the energytransmitter having an external second coil and a second electroniccircuit connected to the second coil. The external second coil of theenergy transmitter transmits wireless energy which is received by thefirst coil of the energy receiver. This system further comprises afeedback device for communicating out the amount of energy received inthe first coil as a feedback information, and wherein the secondelectronic circuit includes a determination device for receiving thefeedback information and for comparing the amount of transferred energyby the second coil with the feedback information related to the amountof energy received in the first coil to obtain the coupling factorbetween the first and second coils. The energy transmitter may regulatethe transmitted energy in response to the obtained coupling factor.

With reference to FIG. 33, although wireless transfer of energy foroperating the device has been described above to enable non-invasiveoperation, it will be appreciated that the device can be operated withwire bound energy as well. Such an example is shown in FIG. 33, whereinan external switch 3260 is interconnected between the external energysource 3040 a and an operation device, such as an electric motor 3070operating the device 10. An external control unit 3040 b controls theoperation of the external switch 3260 to effect proper operation of thedevice 10.

FIG. 34 illustrates different embodiments for how received energy can besupplied to and used by the device 10. Similar to the example of FIG.32, an internal energy receiver 3020 receives wireless energy E from anexternal energy source 3040 a which is controlled by a transmissioncontrol unit 3040 b. The internal energy receiver 3020 may comprise aconstant voltage circuit, indicated as a dashed box “constant V” in thefigure, for supplying energy at constant voltage to the device 10. Theinternal energy receiver 3020 may further comprise a constant currentcircuit, indicated as a dashed box “constant C” in the figure, forsupplying energy at constant current to the device 10.

The device 10 comprises an energy consuming part 10 a, which may be amotor, pump, restriction device, or any other medical appliance thatrequires energy for its electrical operation. The device 10 may furthercomprise an energy storage device 10 b for storing energy supplied fromthe internal energy receiver 3020. Thus, the supplied energy may bedirectly consumed by the energy consuming part 10 a, or stored by theenergy storage device 10 b, or the supplied energy may be partlyconsumed and partly stored. The device 10 may further comprise an energystabilizing unit 10 c for stabilizing the energy supplied from theinternal energy receiver 3020. Thus, the energy may be supplied in afluctuating manner such that it may be necessary to stabilize the energybefore consumed or stored.

The energy supplied from the internal energy receiver 3020 may furtherbe accumulated and/or stabilized by a separate energy stabilizing unit3280 located outside the device 10, before being consumed and/or storedby the device 10. Alternatively, the energy stabilizing unit 3280 may beintegrated in the internal energy receiver 3020. In either case, theenergy stabilizing unit 3280 may comprise a constant voltage circuitand/or a constant current circuit.

It should be noted that FIG. 32 and FIG. 34 illustrate some possible butnon-limiting implementation options regarding how the various shownfunctional components and elements can be arranged and connected to eachother. However, the skilled person will readily appreciate that manyvariations and modifications can be made within the scope of the presentinvention.

FIG. 35 schematically shows an energy balance measuring circuit of oneof the proposed designs of the system for controlling transmission ofwireless energy, or energy balance control system. The circuit has anoutput signal centered on 2.5V and proportionally related to the energyimbalance. The derivative of this signal shows if the value goes up anddown and how fast such a change takes place. If the amount of receivedenergy is lower than the energy used by implanted components of thedevice, more energy is transferred and thus charged into the energysource. The output signal from the circuit is typically feed to an A/Dconverter and converted into a digital format. The digital informationcan then be sent to the external energy-transmission device allowing itto adjust the level of the transmitted energy. Another possibility is tohave a completely analog system that uses comparators comparing theenergy balance level with certain maximum and minimum thresholds sendinginformation to external energy-transmission device if the balance driftsout of the max/min window.

The schematic FIG. 35 shows a circuit implementation for a system thattransfers energy to the implanted energy components of the device of thepresent invention from outside of the patient's body using inductiveenergy transfer. An inductive energy transfer system typically uses anexternal transmitting coil and an internal receiving coil. The receivingcoil, L1, is included in the schematic FIG. 18; the transmitting partsof the system are excluded.

The implementation of the general concept of energy balance and the waythe information is transmitted to the external energy transmitter can ofcourse be implemented in numerous different ways. The schematic FIG. 35and the above described method of evaluating and transmitting theinformation should only be regarded as examples of how to implement thecontrol system.

Circuit Details

In FIG. 35 the symbols Y1, Y2, Y3 and so on symbolize test points withinthe circuit. The components in the diagram and their respective valuesare values that work in this particular implementation which of courseis only one of an infinite number of possible design solutions.

Energy to power the circuit is received by the energy receiving coil L1.Energy to implanted components is transmitted in this particular case ata frequency of 25 kHz. The energy balance output signal is present attest point Y1.

Those skilled in the art will realize that the above various embodimentsof the system could be combined in many different ways. For example, theelectric switch 3060 of FIG. 18 could be incorporated in any of theembodiments of FIGS. 21-27, the hydraulic valve shifting device 3140 ofFIG. 21 could be incorporated in the embodiment of FIG. 20, and the gearbox 3240 could be incorporated in the embodiment of FIG. 19. Pleaseobserve that the switch simply could mean any electronic circuit orcomponent.

The embodiments described in connection with FIGS. 32, 34 and 35identify a method and a system for controlling transmission of wirelessenergy to implanted energy consuming components of an electricallyoperable device. Such a method and system will be defined in generalterms in the following.

A method is thus provided for controlling transmission of wirelessenergy supplied to implanted energy consuming components of a device asdescribed above. The wireless energy E is transmitted from an externalenergy source located outside the patient and is received by an internalenergy receiver located inside the patient, the internal energy receiverbeing connected to the implanted energy consuming components of thedevice for directly or indirectly supplying received energy thereto. Anenergy balance is determined between the energy received by the internalenergy receiver and the energy used for the device. The transmission ofwireless energy E from the external energy source is then controlledbased on the determined energy balance.

The wireless energy may be transmitted inductively from a primary coilin the external energy source to a secondary coil in the internal energyreceiver. A change in the energy balance may be detected to control thetransmission of wireless energy based on the detected energy balancechange. A difference may also be detected between energy received by theinternal energy receiver and energy used for the medical device, tocontrol the transmission of wireless energy based on the detected energydifference.

When controlling the energy transmission, the amount of transmittedwireless energy may be decreased if the detected energy balance changeimplies that the energy balance is increasing, or vice versa. Thedecrease/increase of energy transmission may further correspond to adetected change rate.

The amount of transmitted wireless energy may further be decreased ifthe detected energy difference implies that the received energy isgreater than the used energy, or vice versa. The decrease/increase ofenergy transmission may then correspond to the magnitude of the detectedenergy difference.

As mentioned above, the energy used for the medical device may beconsumed to operate the medical device, and/or stored in at least oneenergy storage device of the medical device.

When electrical and/or physical parameters of the medical device and/orphysical parameters of the patient are determined, the energy may betransmitted for consumption and storage according to a transmission rateper time unit which is determined based on said parameters. The totalamount of transmitted energy may also be determined based on saidparameters.

When a difference is detected between the total amount of energyreceived by the internal energy receiver and the total amount ofconsumed and/or stored energy, and the detected difference is related tothe integral over time of at least one measured electrical parameterrelated to said energy balance, the integral may be determined for amonitored voltage and/or current related to the energy balance.

When the derivative is determined over time of a measured electricalparameter related to the amount of consumed and/or stored energy, thederivative may be determined for a monitored voltage and/or currentrelated to the energy balance.

The transmission of wireless energy from the external energy source maybe controlled by applying to the external energy source electricalpulses from a first electric circuit to transmit the wireless energy,the electrical pulses having leading and trailing edges, varying thelengths of first time intervals between successive leading and trailingedges of the electrical pulses and/or the lengths of second timeintervals between successive trailing and leading edges of theelectrical pulses, and transmitting wireless energy, the transmittedenergy generated from the electrical pulses having a varied power, thevarying of the power depending on the lengths of the first and/or secondtime intervals.

In that case, the frequency of the electrical pulses may besubstantially constant when varying the first and/or second timeintervals. When applying electrical pulses, the electrical pulses mayremain unchanged, except for varying the first and/or second timeintervals. The amplitude of the electrical pulses may be substantiallyconstant when varying the first and/or second time intervals. Further,the electrical pulses may be varied by only varying the lengths of firsttime intervals between successive leading and trailing edges of theelectrical pulses.

A train of two or more electrical pulses may be supplied in a row,wherein when applying the train of pulses, the train having a firstelectrical pulse at the start of the pulse train and having a secondelectrical pulse at the end of the pulse train, two or more pulse trainsmay be supplied in a row, wherein the lengths of the second timeintervals between successive trailing edge of the second electricalpulse in a first pulse train and leading edge of the first electricalpulse of a second pulse train are varied.

When applying the electrical pulses, the electrical pulses may have asubstantially constant current and a substantially constant voltage. Theelectrical pulses may also have a substantially constant current and asubstantially constant voltage. Further, the electrical pulses may alsohave a substantially constant frequency. The electrical pulses within apulse train may likewise have a substantially constant frequency.

The circuit formed by the first electric circuit and the external energysource may have a first characteristic time period or first timeconstant, and when effectively varying the transmitted energy, suchfrequency time period may be in the range of the first characteristictime period or time constant or shorter.

A system comprising a device as described above is thus also providedfor controlling transmission of wireless energy supplied to implantedenergy consuming components of the device. In its broadest sense, thesystem comprises a control device for controlling the transmission ofwireless energy from an energy-transmission device, and an implantableinternal energy receiver for receiving the transmitted wireless energy,the internal energy receiver being connected to implantable energyconsuming components of the device for directly or indirectly supplyingreceived energy thereto. The system further comprises a determinationdevice adapted to determine an energy balance between the energyreceived by the internal energy receiver and the energy used for theimplantable energy consuming components of the device, wherein thecontrol device controls the transmission of wireless energy from theexternal energy-transmission device, based on the energy balancedetermined by the determination device.

Further, the system may comprise any of the following:

-   -   A primary coil in the external energy source adapted to transmit        the wireless energy inductively to a secondary coil in the        internal energy receiver.    -   The determination device is adapted to detect a change in the        energy balance, and the control device controls the transmission        of wireless energy based on the detected energy balance change    -   The determination device is adapted to detect a difference        between energy received by the internal energy receiver and        energy used for the implantable energy consuming components of        the device, and the control device controls the transmission of        wireless energy based on the detected energy difference.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy balance change implies that the energy        balance is increasing, or vice versa, wherein the        decrease/increase of energy transmission corresponds to a        detected change rate.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy difference implies that the received energy        is greater than the used energy, or vice versa, wherein the        decrease/increase of energy transmission corresponds to the        magnitude of said detected energy difference.    -   The energy used for the device is consumed to operate the        device, and/or stored in at least one energy storage device of        the device.    -   Where electrical and/or physical parameters of the device and/or        physical parameters of the patient are determined, the        energy-transmission device transmits the energy for consumption        and storage according to a transmission rate per time unit which        is determined by the determination device based on said        parameters. The determination device also determines the total        amount of transmitted energy based on said parameters.    -   When a difference is detected between the total amount of energy        received by the internal energy receiver and the total amount of        consumed and/or stored energy, and the detected difference is        related to the integral over time of at least one measured        electrical parameter related to the energy balance, the        determination device determines the integral for a monitored        voltage and/or current related to the energy balance.    -   When the derivative is determined over time of a measured        electrical parameter related to the amount of consumed and/or        stored energy, the determination device determines the        derivative for a monitored voltage and/or current related to the        energy balance.    -   The energy-transmission device comprises a coil placed        externally to the human body, and an electric circuit is        provided to power the external coil with electrical pulses to        transmit the wireless energy. The electrical pulses have leading        and trailing edges, and the electric circuit is adapted to vary        first time intervals between successive leading and trailing        edges and/or second time intervals between successive trailing        and leading edges of the electrical pulses to vary the power of        the transmitted wireless energy. As a result, the energy        receiver receiving the transmitted wireless energy has a varied        power.    -   The electric circuit is adapted to deliver the electrical pulses        to remain unchanged except varying the first and/or second time        intervals.    -   The electric circuit has a time constant and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the coil is varied.    -   The electric circuit is adapted to deliver the electrical pulses        to be varied by only varying the lengths of first time intervals        between successive leading and trailing edges of the electrical        pulses.    -   The electric circuit is adapted to supplying a train of two or        more electrical pulses in a row, said train having a first        electrical pulse at the start of the pulse train and having a        second electrical pulse at the end of the pulse train, and    -   the lengths of the second time intervals between successive        trailing edge of the second electrical pulse in a first pulse        train and leading edge of the first electrical pulse of a second        pulse train are varied by the first electronic circuit.    -   The electric circuit is adapted to provide the electrical pulses        as pulses having a substantially constant height and/or        amplitude and/or intensity and/or voltage and/or current and/or        frequency.    -   The electric circuit has a time constant, and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the first coil are varied.    -   The electric circuit is adapted to provide the electrical pulses        varying the lengths of the first and/or the second time        intervals only within a range that includes the first time        constant or that is located relatively close to the first time        constant, compared to the magnitude of the first time constant.

FIGS. 36-39 show in more detail block diagrams of four different ways ofhydraulically or pneumatically powering an implanted device according tothe invention.

FIG. 36 shows a system as described above with. The system comprises animplanted device 10 and further a separate regulation reservoir 10130, aone way pump 10090 and an alternate valve 10140.

FIG. 37 shows the device 10 and a fluid reservoir 10130. By moving thewall of the regulation reservoir or changing the size of the same in anyother different way, the adjustment of the device may be performedwithout any valve, just free passage of fluid any time by moving thereservoir wall.

FIG. 38 shows the device 10, a two way pump 10090 and the regulationreservoir 10130.

FIG. 39 shows a block diagram of a reversed servo system with a firstclosed system controlling a second closed system. The servo systemcomprises a regulation reservoir 10130 and a servo reservoir 10500. Theservo reservoir 10500 mechanically controls an implanted device 10 via amechanical interconnection 10540. The device has anexpandable/contactable cavity. This cavity is preferably expanded orcontracted by supplying hydraulic fluid from the larger adjustablereservoir 10520 in fluid connection with the device 10. Alternatively,the cavity contains compressible gas, which can be compressed andexpanded under the control of the servo reservoir 10500.

The servo reservoir 10500 can also be part of the device itself.

In one embodiment, the regulation reservoir is placed subcutaneous underthe patient's skin and is operated by pushing the outer surface thereofby means of a finger. This system is illustrated in FIGS. 40 a-c. InFIG. 40 a, a flexible subcutaneous regulation reservoir 10130 is shownconnected to a bulge shaped servo reservoir 10500 by means of a conduit10110. This bellow shaped servo reservoir 10500 is comprised in aflexible device 10. In the state shown in FIG. 40 a, the servo reservoir10500 contains a minimum of fluid and most fluid is found in theregulation reservoir 10130. Due to the mechanical interconnectionbetween the servo reservoir 10500 and the device 10, the outer shape ofthe device 10 is contracted, i.e., it occupies less than its maximumvolume. This maximum volume is shown with dashed lines in the figure.

FIG. 40 b shows a state wherein a user, such as the patient in with thedevice is implanted, presses the regulation reservoir 10130 so thatfluid contained therein is brought to flow through the conduit 10110 andinto the servo reservoir 10500, which, thanks to its bellow shape,expands longitudinally. This expansion in turn expands the device 10 sothat it occupies its maximum volume, thereby stretching the stomach wall(not shown), which it contacts.

The regulation reservoir 10130 is preferably provided with means 10130 afor keeping its shape after compression. This means, which isschematically shown in FIG. 40 c, will thus keep the device 10 in astretched position also when the user releases the regulation reservoir.In this way, the regulation reservoir essentially operates as an on/offswitch for the system.

An alternative embodiment of hydraulic or pneumatic operation will nowbe described with reference to FIGS. 41 and 42 a-c. The block diagramshown in FIG. 41 comprises with a first closed system controlling asecond closed system. The first system comprises a regulation reservoir10130 and a servo reservoir 10500. The servo reservoir 10500mechanically controls a larger adjustable reservoir 10520 via amechanical interconnection 10540. An implanted device 10 having anexpandable/contactable cavity is in turn controlled by the largeradjustable reservoir 10520 by supply of hydraulic fluid from the largeradjustable reservoir 10520 in fluid connection with the device 10.

An example of this embodiment will now be described with reference toFIG. 42 a-c. Like in the previous embodiment, the regulation reservoiris placed subcutaneous under the patient's skin and is operated bypushing the outer surface thereof by means of a finger. The regulationreservoir 10130 is in fluid connection with a bellow shaped servoreservoir 10500 by means of a conduit 10110. In the first closed system10130, 10110, 10500 shown in FIG. 42 a, the servo reservoir 10500contains a minimum of fluid and most fluid is found in the regulationreservoir 10130.

The servo reservoir 10500 is mechanically connected to a largeradjustable reservoir 10520, in this example also having a bellow shapebut with a larger diameter than the servo reservoir 10500. The largeradjustable reservoir 1052 is in fluid connection with the device 10.This means that when a user pushes the regulation reservoir 10130,thereby displacing fluid from the regulation reservoir 10130 to theservo reservoir 10500, the expansion of the servo reservoir 10500 willdisplace a larger volume of fluid from the larger adjustable reservoir10520 to the device 10. In other words, in this reversed servo, a smallvolume in the regulation reservoir is compressed with a higher force andthis creates a movement of a larger total area with less force per areaunit.

Like in the previous embodiment described above with reference to FIGS.40 a-c, the regulation reservoir 10130 is preferably provided with means10130 a for keeping its shape after compression. This means, which isschematically shown in the figure, will thus keep the device 10 in astretched position also when the user releases the regulation reservoir.In this way, the regulation reservoir essentially operates as an on/offswitch for the system.

1. A device for monitoring an aneurysm of a human or mammal patientcomprising: A sensor placed in relation to a wall portion of theaneurysm for generating a signal corresponding to a parameter related tothe aneurysm or the treatment of the aneurism.
 2. The device accordingto claim 1, wherein the parameter corresponds to the size of theaneurysm.
 3. The device according to claim 2 wherein the parametercorresponds to the diameter of the aneurysm.
 4. The device according toclaim 1 wherein the sensor is a gauge sensor.
 5. The device according toclaim 1 wherein the parameter corresponds to a pressure.
 6. The deviceaccording to claim 5 wherein the pressure corresponds to a pressure froma hydraulic cuff provided around the aneurysm.
 7. The device accordingto claim 5 wherein the pressure corresponds to a pressure from amechanical implantable member provided around the aneurysm.
 8. Thedevice according to claim 5 wherein the pressure corresponds to apressure in a blood vessel.
 9. The device according to claim 5, whereinthe sensor is adapted to measure the pressure exerted on an implantablemember provided around the aneurysm.
 10. The device according to claim1, wherein the sensor is adapted to measure the volume of a hydraulicimplantable member.
 11. A method of treating an aneurysm of a mammalpatient by providing the medical device according to claim 1, comprisingthe steps of: inserting a needle or a tube like instrument into thepatient's abdominal cavity, using the needle or tube like instrument tofill a part of the patient's body with gas and thereby expanding saidabdominal cavity, placing at least two laparoscopic trocars in saidcavity, inserting a camera through one of the laparoscopic trocars intosaid cavity, inserting at least one dissecting tool through one of saidat least two laparoscopic trocars, dissecting an area of an aneurysm ofa blood vessel, placing the device onto said the aneurysmic bloodvessel, and adjusting the pressure the device exerts onto said aneurysm.12. A method of treating an aneurysm of a mammal patient by providingthe medical device according to claim 1, comprising the steps of:inserting a needle or a tube like instrument into the patient'sthoraxial cavity, using the needle or tube like instrument to fill apart of the patient's body with gas and thereby expanding said thoraxialcavity, placing at least two laparoscopic trocars in said cavity,inserting a camera through one of the laparoscopic trocars into saidcavity, inserting at least one dissecting tool through one of said atleast two laparoscopic trocars, dissecting an area of an aneurysm of ablood vessel, placing the device onto said the aneurysmic blood vessel,and adjusting the pressure the device exerts onto said aneurysm.
 13. Amethod of treating an aneurysm of a mammal patient by providing themedical device according to claim 1, said method comprising the stepsof: cutting the skin in the abdominal or thoraxial wall of said mammalpatient, dissecting an area of the aneurysm, placing said device ontosaid aneurysm, and adjusting the pressure said device exerts onto saidaneurysm.
 14. A method of treating an aneurysm of a mammal patient byproviding the medical device according to claim 1, said methodcomprising the steps of: cutting the skin of said mammal patient,dissecting an area of the aneurysm, placing said device onto saidaneurysm, and adjusting the pressure said device exerts onto saidaneurysm.
 15. A system comprising a device according to claim
 1. 16. Thesystem according to claim 15, further comprising at least one switchimplantable in the patient for manually and non-invasively controllingthe device.
 17. The system according to claim 15, further comprising ahydraulic device having an implantable hydraulic reservoir, which ishydraulically connected to the device, wherein the device is adapted tobe non-invasively regulated by manually pressing the hydraulicreservoir.
 18. The system according to claim 15, further comprising awireless remote control for non-invasively controlling the device. 19.The system according to claim 18, wherein the wireless remote controlcomprises at least one external signal transmitter and/or receiver,further comprising an internal signal receiver and/or transmitterimplantable in the patient for receiving signals transmitted by theexternal signal transmitter or transmitting signals to the externalsignal receiver.
 20. The system according to claim 18, wherein thewireless remote control transmits at least one wireless control signalfor controlling the device. 21.-55. (canceled)